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Validation of the StatSensor Creatinine Meter for Testing Blood Before Contrast Computed Tomography Studies

Aumatell, Anthony PhD*; Sharpe, Debbie MHSM*; Reed, Warren BSc (Hons) AppRad

doi: 10.1097/POC.0b013e3181d2d8a5
Original Articles

This small study simultaneously validates a number of handheld Nova StatSensors Creatinine for the determination of creatinine concentration in whole blood before contrast computed tomographic scans. The Nova StatSensor Creatinine achieves an estimated limit of detection and reporting of 12 and 36 μmol/L, respectively. A linear relationship between creatinine blood concentration and detector response was demonstrated, reflected by the StatSensor standard addition calibration curves show a slope of 0.896 (8%) and a 0.982 mean regression value, which were 2% lower or equal to the laboratory reference method (LRM) slope and regression value. In addition, the scatter for all 6 StatSensors, at each standard addition spike level, was 8% compared to the 10% with the patient blood samples for 3 StatSensors. International guidelines accept variations in creatinine concentration measurements lower than 10%. The standard addition method showed the unknown creatinine concentration in pooled blood, measured by 6 StatSensors, was 96 (10) μmol/L, a 6 μmol/L or 7% positive bias compared with the LRM. Similarly, bias plots for patient blood samples showed StatSensors with a small negative bias, attributed to scatter and sampling technique. The LRM, measuring creatinine in serum, and the StatSensor, measuring creatinine in whole blood, seem to closely agree and strongly suggest that both methods are closely comparable.

From the *Radiology Department, Westmead Public Hospital, Westmead; and †Discipline of Medical Radiation Sciences, Faculty of Health Sciences, The University of Sydney, Sydney, New South Wales, Australia.

Reprints: Anthony Aumatell, PhD, Radiology Department, Westmead Public Hospital, Westmead, New South Wales, Australia. E-mail: AnthonyAumatell@hotmail.com.

© 2010 Lippincott Williams & Wilkins, Inc.